Celgene Corp. said Otezla reduced oral ulcers significantly better than placebo in a phase 3 trial in Behcet's disease, a rare, chronic, multisystem inflammatory syndrome.
The Summit, N.J.-based company's study, called Relief, enrolled 207 patients with previously treated Behcet's disease. Oral ulcers are the most common symptom of the disease.
The study met its main goal as patients treated with 30 milligrams of Otezla twice-daily showed a statistically significant reduced number of ulcers at week 12, compared to those who received placebo.
Celgene said trial results also showed significant improvements in multiple secondary goals, including oral ulcer pain, overall disease activity and quality of life.
The most common side effects for Otezla, also known as apremilast, were diarrhea, nausea, headache and upper respiratory tract infection. The drug's safety profile was consistent with previous results.
Celgene plans to submit supplemental new drug applications for Otezla in the U.S. and Japan in the second half of 2018, as well as a type 2 variation to its EU marketing authorization application in 2019.
Symptoms of Behcet's disease include recurrent oral and genital ulcers and skin lesions. The syndrome is most common the Middle East, Asia and Japan. Currently, there are no approved therapies to treat Behcet's disease in the U.S.